ID

31974

Description

Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care; ODM derived from: https://clinicaltrials.gov/show/NCT01163916

Link

https://clinicaltrials.gov/show/NCT01163916

Keywords

Versions (1)
  1. 10/9/18 10/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 9, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Rheumatoid Arthritis NCT01163916

English

Eligibility Rheumatoid Arthritis NCT01163916

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
Description

Indication Adalimumab

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1122087
patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
Description

Adalimumab prescribed newly | infliximab

Data type

boolean

Alias
UMLS CUI [1,1]
C1122087
UMLS CUI [1,2]
C0278329
UMLS CUI [1,3]
C0750546
UMLS CUI [2]
C0666743
patients who completed abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.
Description

Clinical Trials Specified Completed | adalimumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C1122087
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following patients will not be included in the study:
Description

Patients Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332196
patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
Description

Pharmaceutical Preparations At risk Interactions Adalimumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0687133
UMLS CUI [1,4]
C1122087
hypersensitivity to adalimumab
Description

Hypersensitivity Adalimumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1122087
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
lactation
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
age below 18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
infectious diseases including tuberculosis
Description

Communicable Diseases | Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0041296
patients currently participating in another clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Back to the top of the page

Similar models

Eligibility Rheumatoid Arthritis NCT01163916

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Adalimumab
Item
patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
boolean
C3146298 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
Adalimumab prescribed newly | infliximab
Item
patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
boolean
C1122087 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0750546 (UMLS CUI [1,3])
C0666743 (UMLS CUI [2])
Clinical Trials Specified Completed | adalimumab
Item
patients who completed abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1122087 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Patients Excluded
Item
the following patients will not be included in the study:
boolean
C0030705 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Pharmaceutical Preparations At risk Interactions Adalimumab
Item
patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0687133 (UMLS CUI [1,3])
C1122087 (UMLS CUI [1,4])
Hypersensitivity Adalimumab
Item
hypersensitivity to adalimumab
boolean
C0020517 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
lactation
boolean
C0006147 (UMLS CUI [1])
Age
Item
age below 18
boolean
C0001779 (UMLS CUI [1])
Communicable Diseases | Tuberculosis
Item
infectious diseases including tuberculosis
boolean
C0009450 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
Study Subject Participation Status
Item
patients currently participating in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial